american urological association (aua) / society of ......stress urinary incontinence (sui) is a...

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Purpose

Stress urinary incontinence (SUI) is a common problem experienced by many

women. SUI can have a significant negative impact on the quality of life (QOL) of

not only those who suffer from the condition, but also potentially on those friends

and family members whose lives and activities may also be limited. The surgical

options for the treatment of SUI continue to evolve; as such, this guideline and

the associated algorithm aims to outline the currently available treatment

techniques as well as the data associated with each treatment. It should be noted

that some of the data included in the analysis involved techniques that are no

longer commercially available for reasons not necessarily related to outcomes.

Indeed, the panel recognizes that this guideline will require continued literature

review and updating as further knowledge regarding current and future options

continues to develop.

Methodology

A comprehensive search of the literature was performed by ECRI Institute. This

search included articles published between January 1, 2005 and December 31,

2015. To focus the analysis on the most relevant evidence, analysts only

considered articles published in full after January 1, 2005 in the English language

and that reported SUI data for one or more of the Key Questions. An update

abstract search was conducted through September 2016, which pulled in an

additional 66 abstracts related to the key questions of interest. When sufficient

evidence existed, the body of evidence for a particular treatment was assigned a

strength rating of A (high), B (moderate) or C (low) for support of Strong,

Moderate, or Conditional Recommendations. In the absence of sufficient evidence,

additional information is provided as Clinical Principles and Expert Opinions.

GUIDELINE STATEMENTS

PATIENT EVALUATION

1. In the initial evaluation of patients with stress urinary incontinence desiring to

undergo surgical intervention, physicians should include the following

components: (Clinical Principle)

History, including assessment of bother

Physical examination, including a pelvic examination

Objective demonstration of stress urinary incontinence with a comfortably

full bladder (any method)

Assessment of post-void residual urine (any method)

Urinalysis

2. Physicians should perform additional evaluations in patients being considered

Approved by the AUA

Board of Directors

March 2017

Authors’ disclosure of po-

tential conflicts of interest

and author/staff contribu-

tions appear at the end of

the article.

© 2017 by the American

Urological Association

American Urological Association (AUA) /

Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU)

SURGICAL TREATMENT OF FEMALE STRESS URINARY

INCONTINENCE: AUA/SUFU GUIDELINE

Kathleen C. Kobashi, MD, FACS, FPMRS; Michael E. Albo, MD; Roger R. Dmochowski, MD; David A. Ginsberg, MD; Howard B. Goldman, MD; Alexander Gomelsky, MD; Stephen R. Kraus, MD, FACS; Jaspreet S. Sandhu, MD; Tracy Shepler; Jonathan R. Treadwell, PhD; Sandip Vasavada, MD; Gary E. Lemack, MD

Copyright © 2017 American Urological Association Education and Research, Inc.®

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Society of Urodynamics, Female Pelvic Medicine & Urogenital

Reconstruction (SUFU)

for surgical intervention who have the following conditions: (Expert Opinion)

Inability to make definitive diagnosis based on symptoms and initial evaluation

Inability to demonstrate stress urinary incontinence

Known or suspected neurogenic lower urinary tract dysfunction

Abnormal urinalysis, such as unexplained hematuria or pyuria

Urgency-predominant mixed urinary incontinence

Elevated post-void residual per clinician judgment

High grade pelvic organ prolapse (POP-Q stage 3 or higher) if stress urinary incontinence not demonstrated

with pelvic organ prolapse reduction

Evidence of significant voiding dysfunction

3. Physicians may perform additional evaluations in patients with the following conditions: (Expert Opinion)

Concomitant overactive bladder symptoms

Failure of prior anti-incontinence surgery

Prior pelvic prolapse surgery

CYSTOSCOPY AND URODYNAMICS TESTING

4. Physicians should not perform cystoscopy in index patients for the evaluation of stress urinary incontinence

unless there is a concern for urinary tract abnormalities. (Clinical Principle)

5. Physicians may omit urodynamic testing for the index patient desiring treatment when stress urinary

incontinence is clearly demonstrated. (Conditional Recommendation; Evidence Level: Grade B)

6. Physicians may perform urodynamic testing in non-index patients. (Expert Opinion)

PATIENT COUNSELING

7. In patients wishing to undergo treatment for stress urinary incontinence, the degree of bother that their

symptoms are causing them should be considered in their decision for therapy. (Expert Opinion)

8. In patients with stress urinary incontinence or stress-predominant mixed urinary incontinence who wish to

undergo treatment, physicians should counsel regarding the availability of the following treatment options:

(Clinical Principle)

• Observation

• Pelvic floor muscle training (± biofeedback)

• Other non-surgical options (e.g., continence pessary)

• Surgical intervention

9. Physicians should counsel patients on potential complications specific to the treatment options. (Clinical Principle)

10. Prior to selecting midurethral synthetic sling procedures for the surgical treatment of stress urinary incontinence

in women, physicians must discuss the specific risks and benefits of mesh as well as the alternatives to a mesh

sling. (Clinical principle)

TREATMENT

11. In patients with stress urinary incontinence or stress-predominant mixed urinary incontinence, physicians may

offer the following non-surgical treatment options: (Expert Opinion)

Continence pessary

Vaginal inserts

Pelvic floor muscle exercises

12. In index patients considering surgery for stress urinary incontinence, physicians may offer the following options:

(Strong Recommendation; Evidence Level: Grade A)

Midurethral sling (synthetic)

Stress Urinary Incontinence


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Autologous fascia pubovaginal sling

Burch colposuspension

Bulking agents

13. In index patients who select midurethral sling surgery, physicians may offer either the retropubic or

transobturator midurethral sling. (Moderate Recommendation; Evidence Level: Grade A)

14. Physicians may offer single-incision slings to index patients undergoing midurethral sling surgery with the patient

informed as to the immaturity of evidence regarding their efficacy and safety. (Conditional Recommendation;

Evidence Level: Grade B)

15. Physicians should not place a mesh sling if the urethra is inadvertently injured at the time of planned midurethral

sling procedure. (Clinical Principle)

16. Physicians should not offer stem cell therapy for stress incontinent patients outside of investigative protocols.

(Expert Opinion)

SPECIAL CASES

17. In patients with stress urinary incontinence and a fixed, immobile urethra (often referred to as ‘intrinsic sphincter

deficiency’) who wish to undergo treatment, physicians should offer pubovaginal slings, retropubic midurethral

slings, or urethral bulking agents. (Expert Opinion)

18. Physicians should not utilize a synthetic midurethral sling in patients undergoing concomitant urethral

diverticulectomy, repair of urethrovaginal fistula, or urethral mesh excision and stress incontinence surgery.


19. Physicians should strongly consider avoiding the use of mesh in patients undergoing stress incontinence surgery

who are at risk for poor wound healing (e.g., following radiation therapy, presence of significant scarring, poor

tissue quality). (Expert Opinion)

20. In patients undergoing concomitant surgery for pelvic prolapse repair and stress urinary incontinence, physicians

may perform any of the incontinence procedures (e.g., midurethral sling, pubovaginal sling, Burch

colposuspension). (Conditional Recommendation; Evidence Level: Grade C)

21. Physicians may offer patients with stress urinary incontinence and concomitant neurologic disease affecting lower

urinary tract function (neurogenic bladder) surgical treatment of stress urinary incontinence after appropriate

evaluation and counseling have been performed. (Expert Opinion)

22. Physicians may offer synthetic midurethral slings, in addition to other sling types, to the following patient

populations after appropriate evaluation and counseling have been performed: (Expert Opinion)

Patients planning to bear children

Diabetes

Obesity

Geriatric

OUTCOMES ASSESSMENT

23. Physicians or their designees should communicate with patients within the early postoperative period to assess if

patients are having any significant voiding problems, pain, or other unanticipated events. If patients are

experiencing any of these outcomes, they should be seen and examined. (Expert Opinion)

24. Patients should be seen and examined by their physicians or designees within six months post-operatively.

Patients with unfavorable outcomes may require additional follow-up. (Expert Opinion)

The subjective outcome of surgery as perceived by the patient should be assessed and documented.

Patients should be asked about residual incontinence, ease of voiding/force of stream, recent urinary tract

infection, pain, sexual function and new onset or worsened overactive bladder symptoms.

A physical exam, including an examination of all surgical incision sites, should be performed to evaluate






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healing, tenderness, mesh extrusion (in the case of synthetic slings), and any other potential abnormalities.

A post-void residual should be obtained.






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INTRODUCTION

PURPOSE

Stress urinary incontinence (SUI) is a common problem

experienced by many women. SUI can have a

significant negative impact on the quality of life (QOL)

of not only those who suffer from the condition, but

also potentially on those friends and family members

whose lives and activities may also be limited. The

surgical options for the treatment of SUI continue to

evolve; as such, this guideline and the associated

algorithm aims to outline the currently available

treatment techniques as well as the data associated

with each treatment. It should be noted that some of

the data included in the analysis involved techniques

that are no longer commercially available for reasons

not necessarily related to outcomes. Indeed, the panel

recognizes that this guideline will require continued

literature review and updating as further knowledge

regarding current and future options continues to

develop.

METHODOLOGY

Systematic Review. A comprehensive search of the

literature was performed by ECRI Institute. This search

included articles published between January 1, 2005

and December 31, 2015. Study designs included

systematic reviews, randomized controlled trials

(RCTs), controlled clinical trials (CCTs), and

observational studies (diagnostic accuracy studies,

cohort with and without comparison group, case-

control, case series). Three methodologic research

analysts reviewed the abstracts identified in the

literature search; each article was screened by at least

two of the three analysts. Articles that potentially

fulfilled the outlined inclusion criteria and potentially

answered one or more of the questions specified by the

panel were retrieved in full text for review by the team.

For all excluded studies, analysts recorded the reason

for exclusion as well as whether the exclusion was

based on abstract review or full text review. To focus

the analysis on the most relevant evidence, analysts

only considered articles published in full after January

1, 2005 in the English language and that reported SUI

data for one or more of the Key Questions. An update

abstract search was conducted through September

2016, which pulled in an additional 66 abstracts related

to the key questions of interest.

Included interventions: Included interventions were

limited to those that were FDA-approved with adequate

robust data. Injectable bulking agents (Macroplastique,

Coaptite, Contigen [collagen], silicone, Durasphere

[carbon coated zirconium beads]); retropubic bladder

neck suspensions (Burch colposuspension); midurethral

slings(MUS) (retropubic [SPARC, TVT, ALIGN, Supris,

Advantage, Lynx, Desara, I-STOP, TFS], transobturator

[TVT-O, Monarc, ALIGN TO, Obtryx, Aris], Prepubic,

Adjustable [Remeex]); pubovaginal slings (PVS)

(autologous, allograft, xenograft); artificial urinary

sphincter; single incision (Altis, MiniArc, Ajust, Solyx,

SIMS, TVT-Secure)

Excluded interventions: Laparoscopic colposuspension*,

Obtape, ProteGen, Gore-Tex, bone-anchor,

multifilament, In-Fast, anterior vaginal wall sling,

Renessa, stem cell/tissue engineering, adjustable

continence therapy, Bulkamid, MMK (Marshall-Marchetti

-Krantz), needle suspensions (Stamey, Pereyra, Raz,

Gittes), anterior colporrhaphy, Kelly plication.

*While the Panel acknowledges that a minimally

invasive Burch colposuspension may be utilized by

some individuals, neither laparoscopic nor robotic Burch

colposuspension, specifically, were included due to the

lack of sufficient data regarding these approaches in

the literature.

Included comparisons: Any comparisons of two or more

of the included interventions was incorporated, though

not all comparisons within a given category (e.g.,

comparisons of two bulking agents, or comparisons of

two retropubic midurethral slings [RMUS]) were

included. Additionally, analysts compared bottom-up

versus top-down RMUS, as well as outside-in versus

inside-out transobturator midurethral slings (TMUS).

The following outcomes are included in this review:

QOL questionnaires (symptom, QOL, sexual function,

satisfaction, expectation, bother), voiding diaries,

stress test, pad test, urodynamics, surgical

complications/adverse events, need for retreatment,

UITN-based criteria, and complications (e.g., erosion,

extrusion, retention, voiding dysfunction, perforation,

dyspareunia, obstruction, exposure, de novo urgency,

recurrent urinary tract infection [UTI], bleeding, pain,

neuropathy, neurovascular or visceral injury,

hematoma, infection, hernia, seroma, slow stream).

Many studies reported rates of “success” or “failure,”

which was defined differently by different studies.

Generally, outcomes were based on a set of variables

such as stress tests, patient reports, and the need for

retreatment.

Of the 450 publications retrieved for full review, 256

were excluded. The most common reasons for exclusion

were RCTs that were a part of already included

systematic reviews to avoid duplication.






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Data Extraction and Data Management. Information

from each included article was extracted by one of

three analysts using standard extraction forms. The

team lead developed the forms and trained the

extractors. The lead reviewed the work of the other

extractors and searched for inconsistencies and missing

information in the extracted data.

Assessment of Quality. Because different Key

Questions involved different types of evidence, analysts

tailored the quality assessments as follows:

For systematic reviews, analysts rated quality

based on the review authors’ ratings of the quality

of their included studies (if review authors did not

rate quality, analysts extrapolated a rating based

on their description of study limitations). For

diagnostic cohort studies, analysts used the

QUADAS-2 instrument.1

In reviewing effectiveness, analysts judged the

quality of systematic reviews and RCTs using the

same processes as previously discussed.

For complications, analysts divided the evidence

into comparative data (comprising systematic

reviews and RCTs) and non-comparative data

(comprising individual groups from RCTs and non-

randomized studies).

For comparative data, analysts used the same

processes as previously discussed. For non-

comparative data, analysts considered three items:

prospective design, consecutive enrollment, and

objective measurement of outcome. If all three

were clearly true, the study was high quality; if just

one was false or unclear, the study was moderate

quality. If two or three were false or unclear, the

study was low quality.

In reviewing contraindications for MUS and

indications for injectables, analysts did not assess

quality because those questions involve patient

enrollment criteria.

In reviewing preoperative cystoscopy, analysts

identified no studies on the effect of preoperative

cystoscopy, so no quality assessment was

necessary.

For urodynamics, analysts judged the quality of

randomized trials using the Cochrane risk-of-bias

instrument.2

For patient factors predicting outcomes, analysts

used the Quality in Prognostic Studies (QUIPS)

tool.3

In reviewing outcomes instruments, analysts did

not assess quality since it is not clear what would

constitute a high quality study of instruments

utilized to assess such outcomes.

In reviewing length of follow-up, analysts judged

quality solely on the basis of the percentage of

enrolled patients who provided data during follow-

up. Studies for which all follow up time points had

85%+ completion were deemed high quality;

studies for which any follow up time point had 60%

or less completion were deemed low quality; all

others were deemed moderate quality.

Determination of Evidence Strength. The

categorization of evidence strength is conceptually

distinct from the quality of individual studies. Evidence

strength refers to the body of evidence available for a

particular question and includes not only individual

study quality but consideration of study design,

consistency of findings across studies, adequacy of

sample sizes, and generalizability of samples, settings,

and treatments for the purposes of the guideline. The

AUA categorizes body of evidence strength as Grade A

(well-conducted and highly-generalizable RCTs or

exceptionally strong observational studies with

consistent findings), Grade B (RCTs with some

weaknesses of procedure or generalizability or

moderately strong observational studies with consistent

findings), or Grade C (RCTs with serious deficiencies of

procedure or generalizability or extremely small sample

sizes or observational studies that are inconsistent,

have small sample sizes, or have other problems that

potentially confound interpretation of data). By

definition, Grade A evidence is evidence about which

the Panel has a high level of certainty, Grade B

evidence is evidence about which the Panel has a

moderate level of certainty, and Grade C evidence is

evidence about which the Panel has a low level of

certainty.4

AUA Nomenclature: Linking Statement Type to

Evidence Strength. The AUA nomenclature system

explicitly links statement type to body of evidence

strength, level of certainty, magnitude of benefit or

risk/burdens, and the Panel’s judgment regarding the

balance between benefits and risks/burdens (Table 1).

Strong Recommendations are directive

statements that an action should (benefits outweigh

risks/burdens) or should not (risks/burdens outweigh

benefits) be undertaken because net benefit or net






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harm is substantial. Moderate Recommendations are

directive statements that an action should (benefits

outweigh risks/burdens) or should not (risks/burdens

outweigh benefits) be undertaken because net benefit

or net harm is moderate. Conditional Recommendations

are non-directive statements used when the evidence

indicates that there is no apparent net benefit or harm

or when the balance between benefits and risks/burden

is unclear. All three statement types may be supported

by any body of evidence strength grade. Body of

evidence strength Grade A in support of a Strong or

Moderate Recommendation indicates that the statement

can be applied to most patients in most circumstances

and that future research is unlikely to change

confidence. Body of evidence strength Grade B in

support of a Strong or Moderate Recommendation

indicates that the statement can be applied to most

patients in most circumstances but that better evidence

could change confidence. Body of evidence strength

Grade C in support of a Strong or Moderate

Recommendation indicates that the statement can be

applied to most patients in most circumstances but that

better evidence is likely to change confidence. Body of

evidence strength Grade C is only rarely used in

support of a Strong Recommendation. Conditional

Recommendations also can be supported by any

evidence strength. When body of evidence strength is

Grade A, the statement indicates that benefits and

risks/burdens appear balanced, the best action depends

on patient circumstances, and future research is

unlikely to change confidence. When body of evidence

strength Grade B is used, benefits and risks/burdens

appear balanced, the best action also depends on

individual patient circumstances and better evidence

could change confidence. When body of evidence

strength Grade C is used, there is uncertainty regarding

the balance between benefits and risks/burdens,

alternative strategies may be equally reasonable, and

better evidence is likely to change confidence.

Where gaps in the evidence existed, the Panel provides

guidance in the form of Clinical Principles or Expert

Opinion w ith consensus achieved using a modified

Delphi technique if differences of opinion emerged.5 A

Clinical Principle is a statement for which there may or

may not be evidence in the medical literature and that

is widely agreed upon by urologists or other clinicians.

Expert Opinion refers to a statement for which there is

no evidence and that is achieved by consensus of the

Panel.

Process. The Surgical Management of Female Stress

Urinary Incontinence Panel was created in 2014 by the

American Urological Association Education and

Research, Inc. (AUA). The Practice Guidelines

Committee (PGC) of the AUA selected the Panel Chair

who in turn appointed the Vice Chair. In a collaborative

process, additional Panel members, including additional

members of the Society of Urodynamics, Female Pelvic

Medicine & Urogenital Reconstruction (SUFU) with

specific expertise in this area, were then nominated and

approved by the PGC. The AUA conducted a thorough

peer review process. The draft guidelines document

was distributed to 93 peer reviewers, 41 of which

submitted comments. The Panel reviewed and

discussed all submitted comments and revised the draft

as needed. Once finalized, the guideline was submitted

for approval to the PGC and Science and Quality Council

(S&Q). It was then submitted to the AUA and SUFU

Boards of Directors for final approval. Panel members

received no remuneration for their work.

BACKGROUND

SUI is a common problem experienced by women. The

prevalence of SUI has been reported to be as high as

49%, depending on population and definition, and it

can have a significant negative impact on an

individual's QOL and on that of her family and friends.6-

8 While many women choose surgical management for

their SUI, the specific options for surgical treatment

have evolved over time.9 The first AUA Female SUI

Guidelines Panel reviewed available literature up to

1994 while the literature search for the SUI Guidelines

Panel that directly preceded the present iteration

concluded in June 2005.10 Indeed, the Panel recognized

that given the rapidly changing landscape, this

guideline would require ongoing literature review and

continual updates to keep up with further developments

in the management of SUI.

INDEX PATIENT

The index patient for this guideline, as in the previous

iterations of the SUI guidelines, is an otherwise healthy

female who is considering surgical therapy for the

correction of pure stress and/or stress-predominant

mixed urinary incontinence (MUI) who has not

undergone previous SUI surgery. Patients with low-

grade pelvic organ prolapse were also considered to be

index patients. However, while the stage of prolapse

was often specified in more recent trials, it was not

indicated in many of the earlier studies. Where

evidence was available, the data is presented

separately for index patients and non-index patients.

The Panel recognizes that many women who seek

surgical correction of SUI do not meet the definition of

the index patient. In fact, most of the studies in the

literature do not enroll patients based on this definition






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TABLE 1: AUA Nomenclature Linking Statement Type

to Level of Certainty, Magnitude of Benefit or Risk/Burden, and Body of Evidence Strength

Evidence Strength A

(High Certainty)

Evidence Strength B

(Moderate Certainty)

Evidence Strength C

(Low Certainty)

Strong

Recommendation

(Net benefit or harm sub-

stantial)

Benefits > Risks/Burdens (or vice versa)

Net benefit (or net harm)

is substantial

Applies to most patients in most circumstances and future research is unlikely to change confi-dence



is substantial

Applies to most patients in most circumstances but better evidence could change confidence



appears substantial

Applies to most patients in most circumstances but bet-ter evidence is likely to change confidence

(rarely used to support a

Strong Recommendation)

Moderate

Recommendation

(Net benefit or harm

moderate)



is moderate

Applies to most patients in most circumstances and future research is unlikely to change confi-dence



is moderate

Applies to most patients in most circumstances but better evidence could change confidence



appears moderate

Applies to most patients in most circumstances but bet-ter evidence is likely to change confidence

Conditional

Recommendation

(No apparent net benefit

or harm)

Benefits = Risks/Burdens

Best action depends on individual patient circum-

stances

Future research unlikely to change confidence

Benefits = Risks/Burdens

Best action appears to depend on individual pa-

tient circumstances

Better evidence could change confidence

Balance between Benefits & Risks/Burdens unclear

Alternative strategies may

be equally reasonable

Better evidence likely to change confidence

Clinical Principle

A statement about a component of clinical care that is widely agreed upon by urolo-gists or other clinicians for which there may or may not be evidence in the medical literature

Expert Opinion

A statement, achieved by consensus of the Panel, that is based on members' clinical training, experience, knowledge, and judgment for which there is no evidence






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of the index patient. Therefore, the Panel felt it was

also important to review the literature regarding

patients undergoing surgery for SUI that did not meet

this definition of the index patient.

NON-INDEX PATIENT

Non-index patients reviewed in this analysis include

women with SUI and pelvic prolapse (stage 3 or 4),

MUI (non-stress-predominant), incomplete emptying/

elevated post-void residual (PVR) and/or other voiding

dysfunction, prior surgical interventions for SUI,

recurrent or persistent SUI, mesh complications, high

body mass index (BMI), neurogenic lower urinary tract

dysfunction and advanced age (geriatric). Finally, the

Panel felt it was important to more fully understand the

literature regarding the safety of mesh products used in

the surgical treatment of SUI and, therefore, included

studies of women who had undergone mesh procedures

regardless of whether they were index or non-index

patients. The Panel also acknowledges that persistent

or recurrent SUI following any SUI treatment is not

uncommon; however, there is a lack of robust data to

substantiate any recommendation from the Panel

regarding the management of these patients.

DEFINITIONS

SUI is the symptom of urinary leakage due to increased

abdominal pressure, which can be caused by activities

such as sneezing, coughing, exercise, lifting, and

position change. Though the utility of urethral function

assessment remains controversial, some clinicians

utilize leak point pressure and others utilize urethral

closure pressure. Intrinsic sphincter deficiency (ISD) is

often defined as a leak point pressure of less than 60

cm H20 or a maximal urethral closure pressure of less

than 20 cm H20, often in the face of minimal urethral

mobility. Urgency urinary incontinence (UUI) is the

symptom of urinary leakage that occurs in conjunction

with the feeling of urgency and a sudden desire to

urinate that cannot be deferred. Mixed incontinence

refers to a combination of SUI and UUI.

GUIDELINE STATEMENTS

PATIENT EVALUATION

1. In the initial evaluation of patients with stress

urinary incontinence desiring to undergo

surgical intervention, physicians should

include the following components: (Clinical

Principle)

Focused history, including assessment of

bother

Focused physical examination, including a

pelvic examination

Objective demonstration of stress urinary

incontinence with a comfortably full

bladder(any method)

Assessment of post-void residual urine

(any method)

Urinalysis

2. Physicians should perform additional

evaluations in patients being considered for

surgical intervention who have the following

conditions: (Expert Opinion)

Inability to make definitive diagnosis

based on symptoms and initial evaluation

Inability to demonstrate stress urinary

incontinence

Known or suspected neurogenic lower

urinary tract dysfunction

Abnormal urinalysis, such as unexplained

hematuria or pyuria

Urgency-predominant mixed urinary

incontinence

Elevated post-void residual per clinician

judgment

High grade pelvic organ prolapse (POP-Q

stage 3 or higher) if stress urinary

incontinence not demonstrated by pelvic

organ prolapse reduction

Evidence of significant voiding dysfunction

3. Physicians may perform additional evaluations

in patients with the following conditions:

(Expert Opinion)

Concomitant overactive bladder symptoms

Failure of prior anti-incontinence surgery

Prior pelvic prolapse surgery

The purpose of the diagnostic evaluation in the

incontinent woman is to document, confirm, and

characterize SUI; to assess the differential diagnosis

and comorbidities; and to prognosticate and aid in the

selection of treatment. The first goal of the diagnostic

evaluation is to confirm the diagnosis of SUI and

optimally characterize the incontinence. The literature

search regarding the optimal evaluation for the index






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patient yielded two systematic reviews11,12 and four

individual studies that addressed this issue.13-16 The

role of six variables was assessed: history,

questionnaires/scales, stress test, Q-tip test, pad test,

and urodynamics. Additional tests, including urinalysis,

pelvic examination, prolapse assessment, cystoscopy,

PVR volume, and voiding diary, yielded no additional

meaningful evidence.

History. Holroyd-Leduc et al. performed a moderate-

quality systematic review of various methods for

diagnosing urinary incontinence during office

assessment.11 A meta-analysis of 10 cohort studies with

2,657 patients found that the presence of coughing,

sneezing, lifting, walking, or running as initiators of

incontinence increased the likelihood of SUI as the

cause of urinary leakage, while their absence decreased

the likelihood of SUI. Thus, a woman with a positive

clinical history had a 74% chance of having SUI,

whereas a woman with a negative clinical history had a

34% chance of having SUI. Likewise, in a systematic

review by Martin et al. that combined data from 15

cohort studies with 3,545 patients, a woman with a

positive clinical history had a 73% chance of having

SUI, whereas a woman with a negative clinical history

had a 16% chance of having SUI.12 Thus, the evidence

from two moderate-quality meta-analyses suggests

that clinical history provides some diagnostic value for

patients with signs/symptoms potentially caused by

SUI; however, history alone, while helpful, does not

definitively diagnose SUI in women.

Questionnaires. Eight questionnaires were

assessed in the two systematic reviews for their ability

to diagnose SUI.11,12 While most questionnaires showed

small positive and negative likelihood ratios (LRs) for

diagnosing or ruling out SUI, the limited number of

studies for each questionnaire resulted in an overall

strength of evidence of low. It is important to note that

an assessment of bother, regardless of method or

questionnaire, is paramount to the decision to operate

in the index patient. Since SUI is a condition that

impacts QOL (rather than quantity of life), the

treatment decisions should be closely linked to the

ability to improve bother caused by the symptoms. If

bother is minimal, then strong consideration should be

given to non-surgical management.

Stress test. Two moderate-quality systematic

reviews and one additional study evaluated stress tests

for diagnosis of SUI using urodynamic evaluations as

the reference standard. While stress tests were

performed under different protocols (e.g. retrograde

filling with 200 mL saline; 20 minutes after

catheterization for PVR volume), a positive stress test

had a high sensitivity and specificity for detecting SUI

on urodynamics. Similar results were obtained in a

single study that combined the supine and standing

stress test.17 However, since this combined test was

evaluated in only one study, the strength of evidence

supporting it is low. Additionally, in a secondary

analysis of an RCT by Albo et al., the sensitivity and

specificity of the supine empty bladder stress test to

predict ISD were 49% and 60%, respectively,

suggesting that the supine stress test did not identify

ISD.13

Q-tip test. Holroyd-Leduc et al. included two studies

with a total of 253 patients that evaluated the Q-tip

test, with one study using a cutoff angle of 20° and the

other 35°.11 Both studies used urodynamic tests as the

reference standard and the pooled positive LR was very

small, suggesting that a positive test is unlikely to aid

in the diagnosis of SUI. Intuitively, this makes sense,

since SUI may exist without urethral hypermobility and

vice versa. Thus, moderate strength evidence suggests

that a positive Q-tip test has little value for diagnosis of

SUI, and this test cannot be recommended by the panel

to diagnose SUI. However, it can provide some

potentially useful information regarding the degree of

urethral mobility.

Pad test. The review by Holroyd-Leduc et al.

included one study with 105 patients (Versi et al.)18

that compared the 48-hour pad test to a reference

standard of urodynamic findings. Women with a

positive pad test had an 81% chance of having SUI,

whereas women with a negative pad test had a 13%

chance of having SUI. In this study, however, all

patients had either SUI or no incontinence. Thus, the

authors concluded that “the pad test confirms an

incontinence problem, but its role in distinguishing the

type of incontinence cannot be commented on.”

Martin et al. included two studies in their analysis.12

One of these was the Versi study, while the study by

Jorgensen et al.19 compared the one-hour pad test to a

reference standard of urodynamic findings. The latter

study showed a high sensitivity (94%) but low

specificity (44%) for diagnosing SUI. These results

correspond to women with a positive pad test having a

69% chance of having SUI, and women with a negative

pad test having a 15% chance of having SUI. Since

each test was evaluated by only one small study, the

strength of evidence for both tests is low, and

importantly, though a pad test may confirm the

presence of incontinence, it does not distinguish the

specific type of incontinence.






11

After performing a history and physical examination,

including a pelvic examination with a comfortably full

bladder, the diagnosis of SUI may be fairly

straightforward in the index patient. The sine-qua-non

for a definitive diagnosis is a positive stress test, or

witnessing of involuntary urine loss from the urethral

meatus coincident with increased abdominal pressure,

such as occurs with coughing and Valsalva maneuver. If

leakage is not witnessed in the supine position, the test

may be repeated in the standing position to facilitate

the diagnosis. Once the increase in abdominal pressure

has subsided, flow through the urethra should subside

as well. Rarely, one may witness urine loss after an

increase in intra-abdominal pressure has subsided. In

this scenario, the incontinence may be, at least in part,

due to an involuntary detrusor contraction (stress-

induced detrusor overactivity).

The Panel felt that physicians should obtain the

following details from the history, bladder diary,

questionnaires, and/or pad testing.

Characterization of incontinence (stress, urgency,

mixed, continuous, without sensory awareness)

Chronicity of symptoms

Frequency, bother, and severity of incontinence

episodes

Patient’s expectations of treatment (patient-

centered goals)

Pad or protection use

Concomitant urinary tract symptoms (e.g.,

urgency, frequency, nocturia, dysuria, hematuria,

slow flow, hesitancy, incomplete emptying)

Concomitant pelvic symptoms (e.g., pelvic pain,

pressure, bulging, dyspareunia)

Concomitant gastrointestinal symptoms (e.g.,

constipation, diarrhea, splinting to defecate)

Obstetric history (e.g., gravity, parity, method of

delivery)

Previous treatments for incontinence (e.g.,

behavioral therapy, Kegel exercises/pelvic floor

muscle training, pharmacotherapy, surgery)

Previous pelvic surgeries

Past medical history (e.g., hypertension, diabetes,

history of pelvic radiation)

Current and past medications

Fluid, alcohol, and caffeine intake

Menopausal status

Additionally, the physical examination of the index or

non-index patient should include the following

components:

Focused abdominal examination

Evaluation of urethral mobility (any method)

Supine and/or standing stress test with comfortably

full bladder

Assessment of pelvic prolapse (any method)

Assessment of vaginal atrophy/estrogenization

status

Focused neurologic examination

Diagnostic evaluations that should be performed in the

index or non-index patient include the following:

Urinalysis

PVR

The presence of microscopic hematuria may warrant

additional evaluation with upper tract imaging and

cystoscopy. The assessment of PVR may alert the

physician to the potential for incomplete bladder

emptying. Several points deserve mention. First, the

reliability of a single elevated PVR value for predicting

emptying dysfunction remains in question, just as a

single low PVR value does not rule out the presence of

incomplete emptying. Second, the threshold value of a

significant PVR is similarly undefined. Finally, a

persistently elevated PVR does not characterize the

cause of impaired emptying, but rather indicates the

need for further evaluation. Additionally, an elevated

PVR in the presence of SUI may impact patient

counseling regarding surgical interventions and patient

expectations. Elevated PVR may be an indication of

hypocontractility of the bladder and may put a patient

at risk for retention after treatment for SUI.

Consideration of the relationship between incomplete

bladder emptying and UTI should be considered, and a

urinalysis with culture as indicated should be obtained

in patients with elevated PVR in the face of symptoms

of a UTI.

The second goal of a diagnostic evaluation in a woman

with SUI is to assess the differential diagnosis of

incontinence and evaluate the impact of coexisting

conditions. The differential diagnosis of SUI includes

other causes of urethral incontinence, such as overflow






12

incontinence (a clinical diagnosis) and detrusor

overactivity incontinence, low bladder compliance, and

stress-induced detrusor overactivity (urodynamic

diagnoses). Other anatomic findings such as pelvic

organ prolapse and number and location of ureteral

orifices can be diagnosed by physical examination and

cystoscopy, respectively. Similarly, additional functional

conditions, such as urethral obstruction and impaired or

absent contractility, can be identified via urodynamics

testing, including cystometry, non-invasive uroflow,

pressure-flow study, and PVR assessment. Urinary

incontinence may also occur due to a urethral

diverticulum, a urinary fistula, or an ectopic ureter.

These entities are often suspected on the basis of

history and examination, but generally require

cystoscopy and other urinary tract imaging for

confirmation.

Certain coexistent conditions may influence surgical

technique, impact the outcomes of treatment, and

influence the nuances of patient counseling. For

example, a patient with MUI who has a large PVR

volume and detrusor underactivity might be counseled

that her urgency symptoms may persist and that there

is a potential for urinary retention following surgical

treatment of SUI. Furthermore, surgical technique

might be tailored based on some anatomic features and

the presence of concomitant urinary urgency and UUI.

The third goal of the diagnostic evaluation is to aid in

prognosis and selection of treatment. There are few

facts and many opinions about predicting the outcome

of surgery based on the conditions described above.

However few clinicians would disagree that operations

for SUI should be confined to those who have

demonstrable SUI, including occult SUI demonstrable

only after reduction of pelvic organ prolapse.

Nevertheless, an understanding of the specific

concomitant conditions facilitates individualized

treatment planning and informed consent. It also

provides the surgeon information with which to

formulate a sense regarding potential outcome and

possible complications such as incomplete bladder

emptying, persistent, worsened, or de novo urgency/

UUI, and recurrent sphincteric incontinence.

Urodynamic evaluation may be of assistance in

elucidating complex presentations of incontinence.

Additional evaluation should also be performed in

women with suspected neurogenic etiology for their

incontinence or in women with evidence of

dysfunctional voiding. Women who present with

persistent or recurrent SUI after previous definitive

surgical intervention may also benefit from additional

evaluation. Likewise, in select patients with

symptomatic SUI in whom SUI cannot be

demonstrated, additional evaluation may be beneficial.

It must be mentioned that the need for further

evaluation of any given patient depends upon a number

of additional factors, including the physician’s degree of

certainty and comfort regarding the accuracy of the

diagnosis, the degree of bother the symptoms are

causing the patient, the impact that further studies will

have on diagnosis, and treatment risks, options, and

likely outcomes. The desire and willingness of the

patient to undergo further studies should also be taken

into consideration.

CYSTOSCOPY AND URODYNAMICS TESTING

4. Physicians should not perform cystoscopy in

index patients for the evaluation of stress

urinary incontinence unless there is a concern

for urinary tract abnormalities. (Clinical

Principle)

The consensus of the Panel is that there is no role for

cystoscopy in the evaluation of patients considering

surgical therapy for SUI who are otherwise healthy and

have a normal urinalysis. However, if these patients

elect surgical therapy, intraoperative cystoscopy should

be performed with certain surgical procedures (e.g.,

midurethral or pubovaginal fascial slings) to confirm the

integrity of the lower urinary tract and the absence of

foreign body within the bladder or urethra.

Cystoscopy should be performed as indicated in

patients in whom bladder pathology is suspected based

on history or concerning findings on physical exam or

urinalysis. In particular, cystoscopy should be

performed in patients found to have microhematuria on

urinalysis with microscopy. A cystoscopy should also be

performed in patients in whom there is a concern for

structural lower urinary tract abnormalities.

The consensus of panel members is that cystoscopy

should be performed in patients who have a history of

prior anti-incontinence surgery or pelvic floor

reconstruction, particularly if mesh or suture

perforation is suspected. This suspicion may be based

upon new onset of lower urinary tract symptoms,

hematuria, or recurrent UTI.

5. Physicians may omit urodynamic testing for

the index patient desiring treatment when

stress urinary incontinence is clearly

demonstrated. (Conditional Recommendation;

Evidence Level: Grade B)

Urodynamics testing is not necessary in otherwise

healthy patients during initial patient evaluation or to

determine outcomes after surgery. The role of






13

urodynamics in patients with uncomplicated SUI (pure

SUI or stress-predominant MUI) undergoing surgery

was evaluated in the Value of Urodynamic Evaluation

(VALUE) trial.15 The investigators in this large

multicenter RCT compared office evaluation alone to

urodynamics in addition to office evaluation in 630

patients and showed no difference in outcomes as

measured by clinical reduction in complaints measured

by the Urinary Distress Inventory and the Patient

Global Impression of Improvement (PGI-I).

Another RCT did show that urodynamics in addition to

office evaluation lead to better outcomes than office

evaluation alone.16 However, the conclusions of this

study were weakened by the low enrollment of only 72

patients, 12 of whom were excluded from the

urodynamics arm because of “unfavorable parameters”

for surgery, including detrusor overactivity, and

valsalva leak point pressure (VLPP) less than 60 cm

H2O.

6. Physicians may perform urodynamic testing in

non-index patients. (Expert Opinion)

In certain patients, urodynamic testing should be

considered. Urodynamic testing may be performed at

the urologist’s discretion in certain non-index patients,

including but not limited to those patients listed below

to facilitate diagnosis, treatment planning, and

counseling:

History of prior anti-incontinence surgery

History of prior pelvic organ prolapse surgery

Mismatch between subjective and objective

measures

Significant voiding dysfunction

Significant urgency, UUI, overactive bladder (OAB)

Elevated PVR per clinician judgment

Unconfirmed SUI

Neurogenic lower urinary tract dysfunction

PATIENT COUNSELING

7. In patients wishing to undergo treatment for

stress urinary incontinence, the degree of

bother that their symptoms are causing them

should be considered in their decision for

therapy. (Expert Opinion)

Since SUI is a condition that impacts QOL, treatment

decisions should be closely linked to the ability of any

intervention to improve the bother caused to the

patient by her symptoms. If the patient expresses

minimal subjective bother due to the SUI, then strong

consideration should be given to conservative, non–

surgical therapy. To this point, patients should be

counseled on the risks, benefits, and alternatives to any

intervention they may choose in addition to the concept

that the primary goal of treatment is to improve QOL.

8. In patients with stress urinary incontinence or

stress-predominant mixed urinary

incontinence who wish to undergo treatment,

physicians should counsel regarding the

availability of the following treatment options:


Observation

Pelvic floor muscle training (± biofeedback)

Other non-surgical options (e.g., continence

pessary)

Surgical intervention

The Panel believes that patients should be offered all of

the above-mentioned options before a treatment

decision is made. There are a variety of factors that

impact the patient’s final decision with regard to

treatment. Observation is appropriate for patients who

are not bothered enough to pursue further therapy, not

interested in further therapy, or who are not candidates

for other forms of therapy. Pelvic floor muscle training

and incontinence pessaries are appropriate for patients

interested in pursuing therapy that is less invasive than

surgical intervention. Pelvic floor physical therapy can

be augmented with biofeedback in the appropriate

patient. The patient must be willing and able to commit

to regularly and consistently performing pelvic floor

training for this to be successful.

Physicians should educate the patient regarding

appropriate surgical options before treatment decisions

are made. The primary categories of surgical options

include bulking agents, colposuspension, and slings.

Patients should be made aware that slings can be

performed with or without the use of synthetic mesh.

Discussing these various treatment options and their

potential risks and benefits allows the patient to

combine this information with her own goals for

treatment in order to make an informed decision.

9. Physicians should counsel patients on

potential complications specific to the

treatment options. (Clinical Principle)

The potential complications related to a given






14

intervention can play a significant role in the decision-

making process for patients considering treatment for

SUI. Accordingly, physicians need to educate and

counsel patients regarding possible complications, some

of which are non-specific and others that are unique to

the various types of SUI surgery. Patients should be

aware that with any intervention there is a risk of

continued symptoms of SUI immediately after the

procedure or recurrent SUI at a later time that may

require further intervention.

Patients should be made aware of possible intra-

operative risks that can occur with surgery to correct

SUI. These risks include but are not limited to bleeding,

bladder injury, and urethral injury, as well as inherent

risks of anesthesia, and of the procedure itself.

Voiding dysfunction can be seen after any type of

intervention for SUI and may involve both storage and

emptying symptoms. There is a risk of de novo storage

symptoms (urgency, frequency and/or UUI) or

worsening of baseline OAB symptoms for patients with

MUI or SUI with urinary urgency. Depending on the

symptoms, this may require one of the many options

available to treat OAB or, if the symptoms are thought

to be related to post-operative obstruction, may require

sling incision, sling loosening, or urethrolysis.

Obstruction resulting in urinary retention is also a

potential complication and would require intermittent

catheterization, indwelling Foley catheter drainage, and

possible sling incision, sling loosening, or urethrolysis if

this does not resolve spontaneously.

Complaints of abdominal, pelvic, vaginal, groin, and

thigh pain can be seen after sling placement. In

addition to generalized pain, patients should be

counseled about the risk of pain associated with sexual

activity. Symptoms of dyspareunia can occur following

pelvic floor reconstructive surgery.

In patients who are considering a synthetic mesh sling,

counseling regarding the risk of transvaginal mesh

placement is imperative. Risks include mesh exposure

into the vagina and/or perforation into the lower

urinary tract, either of which could require additional

procedures for surgical removal of the involved mesh

and, if necessary, repair of the lower urinary tract.

UTI can occur following any intervention for SUI, and

the incidence appears to be highest in the immediate

postoperative period (within three months). Patients

undergoing autologous fascial sling have the additional

risk of possible wound infection, seroma formation, or

ventral incisional or leg hernia depending on the fascial

harvest site (i.e. rectus fascia versus fascia lata,

respectively), and pain at the harvesting site.

10. Prior to selecting midurethral synthetic sling

procedures for the surgical treatment of

stress urinary incontinence in women,

physicians must discuss the specific risks and

benefits of mesh as well as the alternatives to

a mesh sling. (Clinical principle)

The Panel believes that patients considering surgical

intervention should be counseled regarding the risks

and benefits of the use of synthetic mesh to treat SUI.

This detailed discussion should make clear to the

patient the possible risks, benefits, and alternatives of

MUS. The focus of the discussion should not be on the

superiority of one technique over another; indeed, the

literature does not definitively suggest that MUS is

more or less effective to alternative interventions, such

as PVS or colposuspension.

The focus should be on the benefits, the potential risks,

and the FDA safety communication regarding MUS, thereby allowing the patient to make a goal-oriented, informed decision as to how she would like to approach her SUI treatment. MUS is the most studied surgical treatment for female SUI. Other than bulking agents, MUS is also the least invasive surgical options to treat SUI. Effectiveness is well documented in the short and medium term with increasing evidence supporting its

effectiveness in the long-term as well.20 This volume of literature and length of follow-up is not available for PVS or colposuspension; however, as mentioned above, there is no conclusive evidence that any one of the available sling procedures is superior or inferior to the others with regard to efficacy.

All surgical interventions (MUS, PVS, colposuspension)

to treat SUI have potential adverse outcomes, such as continued incontinence, voiding dysfunction, urinary retention, pain, and dyspareunia. Clinical outcomes appear to be worse for patients who have had prior surgery for SUI, irrespective of the approach. Patients considering MUS should be made aware of the prior FDA public health notifications regarding the use of

transvaginal mesh to treat SUI or pelvic organ prolapse (https://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm262435.htm) and be advised of possible mesh-related risks, such as vaginal exposure (which can also be associated with dyspareunia) and perforation into the lower urinary tract or other neurovascular or visceral symptoms. There does appear to be a greater risk of mesh erosion associated with

diabetes and a history of smoking;21-23 Other factors that have been suggested to portend an increased risk of mesh erosion on multivariate analysis include older age, >2 cm vaginal incision length, and previous vaginal surgery.24 However, a review of the literature did not find an association between obesity, parity,






https://urldefense.proofpoint.com/v2/url?u=https-3A__www.fda.gov_medicaldevices_safety_alertsandnotices_ucm262435.htm&d=DwMFAg&c=-jsIGnQmWcJE-QSZ38WZbwER8vrBdlrW9R02p1M7myU&r=UHFlH2boajjQlFK2r8X6Dq2taUxTTlJrLrd7b9BZSgMe5qy2hmfXV-W8IKEvD6l8&m=yhlxpcMViACIbAN6h

https://urldefense.proofpoint.com/v2/url?u=https-3A__www.fda.gov_medicaldevices_safety_alertsandnotices_ucm262435.htm&d=DwMFAg&c=-jsIGnQmWcJE-QSZ38WZbwER8vrBdlrW9R02p1M7myU&r=UHFlH2boajjQlFK2r8X6Dq2taUxTTlJrLrd7b9BZSgMe5qy2hmfXV-W8IKEvD6l8&m=yhlxpcMViACIbAN6h

15

menopausal status, or use of hormone replacement and mesh-related adverse events.

An additional important resource for patients and

clinicians is the joint SUFU/American Urogynecologic

Society (AUGS) position statement regarding mesh

(http://sufuorg.com/docs/news/augs-sufu-mus-position

-statement.aspx).

TREATMENT

11. In patients with stress urinary incontinence or

stress-predominant mixed urinary

incontinence, physicians may offer the

following non-surgical treatment options:

(Expert Opinion)

Continence pessary

Vaginal inserts

Pelvic floor muscle exercises

Patients may opt for the use of conservative measures

to treat stress or stress-predominant urinary

incontinence. There are no comparative or direct

observational data concerning the use of urethral plugs,

continence pessaries, or vaginal inserts in the

management of these patients. The Panel believes

these are low-risk options to consider in the treatment

of patients. Some basic maintenance should be followed

with these devices, including regular visits to monitor

time of use and tissue quality to minimize

complications. The optimal patient for any of these

treatment options is not currently established.

12. In index patients considering surgery for

stress urinary incontinence, physicians may

offer the following options: (Strong

Recommendation; Evidence Level: Grade A)

Midurethral sling (synthetic)

Autologous fascia pubovaginal sling

Burch colposuspension

Bulking agents

Several surgical options exist for SUI. Choice of

intervention should be individualized based upon the

patient's symptoms, the degree of bother the

symptoms cause the patient, patient goals and

expectations, and the risks and benefits for a given

patient. Although most of these procedures have been

available for some time, very little comparative data

between these broad treatment categories exists to

assist the physician in choosing a therapy.

Midurethral synthetic sling. MUS may be

characterized as retropubic (top-down or bottom-up),

transobturator (inside-out or outside-in), single incision

sling (SIS) or adjustable sling types. Long-term data

exists for several of the slings but vary in their duration

of follow up, in both comparative and non-comparative

analyses. Furthermore, it remains important to assess

the manner in which success was defined in each of

these studies, as definitions vary between series.

Retropubic midurethral synthetic sling (RMUS). Initially

introduced as a bottom-up retropubic approach in the

late 1990s, the TVTTM is arguably the most widely

studied anti-incontinence procedure, with data that

exceeds 15 years follow up.20,25 Success rates are

reported to be between 51 and 87%. The TVTä has also

been the subject of numerous comparative studies. The

retropubic top-down versus bottom-up approach was

evaluated in two publications, one systematic review20

and one additional study.26 Ford et al. (2015) included

five trials with a total of 631 women with SUI or stress-

predominant MUI symptoms that compared these two

procedures.20 The average study quality was moderate.

Definitive superiority for one approach over the other

has not been found; however, results favored the

bottom-up approach in some meta-analyses. In these

studies, a significant reduction in bladder or urethral

perforation, voiding dysfunction, and vaginal tape

erosion was noted with the bottom-up approach. Meta-

analyses regarding other adverse events (perioperative

complications, de novo urgency or urgency

incontinence, and detrusor overactivity) were

inconclusive due to wide confidence intervals.

Accordingly, the Panel does not support one retropubic

method over another.

Transobturator midurethral synthetic sling (TMUS). The

TMUS was developed in an effort to simplify and even

minimize the complication profile realized with the

retropubic approach. Single and multicenter prospective

and retrospective studies have confirmed efficacy with

success rates ranging between 43 and 92% in follow up

of up to 5 years.20 With the possibility that TMUS would

have an improved safety profile over RMUS, it was

natural to do comparative efficacy analyses between

the sling types. Overall, in aggregate, most short-term

analyses that compared RMUS and TMUS found them to

be equivalent. However, long-term comparisons are

relatively lacking. The Trial of Mid-urethral Slings

(TOMUS) compared the short (one and two year) and

long (five year) outcomes of RMUS and TMUS. Short-

term analyses demonstrated statistical equivalence

between the two procedures; however, slight






16

advantages towards the RMUS were seen with longer

follow up (five years).27

The transobturator approaches have both outside-in

and inside-out techniques. Evidence suggests that

these approaches have similar effectiveness.

Single incision synthetic sling (SIS). In another

development toward simplification of the synthetic

sling, the SIS was introduced as a less invasive, lower

morbidity surgery with the potential to maintain

efficacy of the synthetic sling. It should be emphasized

that no long-term data is available with the SIS, but

more recent comparative analyses have become

available. The SIS was compared with bottom-up

RMUS. Overall evidence on effectiveness favors RMUS

over SIS, but most of the SIS trials involved TVT-Secur,

which is a device that has since been withdrawn from

the market for poor results. The average study quality

was moderate, and a five-study meta-analysis indicated

a two-fold difference in success rates in favor of

RMUS.28 Comparison of SIS and TMUS have been

studied with index and non-index patients. Taken in

aggregate, the overall results show equivalence with

the available SIS and TMUS with regard to effectiveness

and sexual function, although the trials are primarily

lower level evidence. Furthermore, there is a lack of

long-term RCT data on SIS compared with other sling

types. Accordingly, there is insufficient comparative

data to favor a SIS over either RMUS or TMUS.

Autologous fascia pubovaginal sling (PVS). The

autologous fascia PVS, which involves the placement of

autologous fascia lata or rectus fascia beneath the

urethra to provide support has been performed for

many years. Using varying definitions, single center

studies have confirmed between 87% and 92% success

with 3-15 year follow up.29-31 Still, comparative

analyses of this time-tested technique have been

lacking until the last decade. Well-controlled and

appropriately blinded comparisons of fascia sling versus

other anti-incontinence procedures is difficult due to the

inherent differences in morbidity of the techniques. The

SISTEr trial compared the fascial sling to the Burch

colposuspension in a well-conducted RCT. Data

suggested effectiveness and need for retreatment

favoring the fascial sling over the Burch

colposuspension (66% versus 49%). This trial used

strict composite outcome criteria of no self-reported

SUI on questionnaire, no need for retreatment, and a

negative stress test. The Panel believes that the

autologous fascia PVS is a viable option for the

management of SUI. The added morbidity of the fascial

harvest should be considered in the preoperative

discussion when considering sling type (see

complications section). Efforts to use other materials,

such as porcine dermis and cadaveric fascia, as

substitution for the autologous fascia have shown

inferior results.32

Colposuspension. While largely supplanted by MUS,

the suture-only based colposuspension still has a role in

the management of SUI, although many would consider

this primarily for patients concerned with the use of

mesh or who are undergoing concomitant open or

minimally invasive (laparoscopic or robotic) abdominal-

pelvic surgery, such as hysterectomy. Comparative

studies of the Burch colposuspension with the TVTTM

showed essentially equivalent outcomes with the TVTTM

in several RCTs. Despite the large number of trials,

results were too sparse to indicate whether there is a

difference between these two treatments. The SISTEr

trial compared the Burch colposuspension with the

autologous fascial PVS. This comparison had outcome

data to five years and favored the autologous fascia

PVS over the Burch colposuspension due to the lower

retreatment rates (4% versus 13%). While no definitive

selection criteria exist for this procedure over others,

the Panel believes colposuspension is a viable approach

for women with SUI who wish to avoid the morbidity of

fascial harvest and also wish to avoid mesh, particularly

if undergoing a simultaneous abdominal procedure,

such as open or minimally invasive hysterectomy. One

should realize that the colposuspension does carry

some morbidity with its incision as shown in the SISTEr

trial with over 20% of patients having wound related

issues. The data also suggest that the colposuspension

is likely inferior to fascial sling in most efficacy related

outcomes.

Bulking agents. The Panel believes that bulking

agents are viable treatments for SUI; however, little

long-term data exists for them. Retreatment tends to

be the norm for bulking agent therapy, and

determination of absolute outcomes accordingly

becomes challenging. There is inadequate data to allow

the recommendation of one injectable agent over

another. Still, the role for bulking agents may best be

considered in patients who wish to avoid more invasive

surgical management or who are concerned with the

lengthier recovery time after surgery or who experience

insufficient improvement following a previous anti-

incontinence procedure. Patients should be counseled

on the expected need for repeat injections.

13. In index patients who select midurethral sling

surgery, physicians may offer either the

retropubic or transobturator midurethral






17

sling. (Moderate Recommendation; Evidence

Level: Grade A)

The selection of RMUS versus TMUS should be

determined by the surgeon based on comfort or

preference and degree of urethral mobility after

discussion with the patient regarding the difference in

risks of adverse events between each procedure.

Five systematic reviews20,33-36 and 11 publications citing

RCT trials were reviewed by the panel. Of the 11 RCTs,

4 enrolled only index patients,37-40 and 7 enrolled

patients with MUI or did not clearly define enrollment.41

-47

The largest systematic review included 55 trials with a

total of 8,652 patients with SUI or stress-predominant

MUI.20 The rates of subjective and objective cure were

similar between TMUS and RMUS in the short-term (up

to 1 year). There were fewer and less robust studies

with medium term (1-5 years) and long-term (>5

years) follow-up with subjective cure rates ranging

from 43-92% for TMUS and 51-88% for RMUS. The

review by Sun et al.33 used more stringent inclusion

criteria than that performed by Ford et al.20 and

included 16 RCTs with a total of 2,646 women with SUI

or MUI. The RCTs in that review included at least 40

patients, no more than 15% loss to follow-up, and

objective cure as an outcome. They performed separate

meta-analyses of studies that evaluated only patients

with isolated SUI (7 trials; index patients) and studies

that evaluated patients with either isolated SUI or MUI

(9 trials; mixed index and non-index patients). The

review was inconclusive with regard to efficacy.

Eleven RCTs investigated comparative efficacy between

the TMUS and RMUS, and the balance of data suggests

similar effectiveness. Four of the 11 RCTs looked

specifically at index-patients: one indicated

equivalence,37 and three38-40 were inconclusive. Of the

remaining seven trials, two found equivalence,41,44 four

were inconclusive,43,45-47 and one42 indicated an

advantage of RMUS. The latter trial, Schierlitz et al.,42

reported that the risk of failure was 15 times greater

(95% CI: 2 to 113) in women who underwent a TMUS

procedure compared to women who underwent an

RMUS procedure. However, it should be noted that all

patients in this trial had ISD based on either VLPP or

maximum urethral closure pressure, which may limit its

applicability. The meta-analysis by Ford et al.20 also

demonstrated a significantly higher rate of repeat

incontinence surgery within five years in the TMUS

group.

Overall, however, some early short-term data

suggested equivalence in incontinence rates after

surgery when comparing TMUS to RMUS in both index

and non-index patients. That being said, robust long-

term data are lacking, and the data from increasing

follow up appear to be demonstrating a lack of

durability of TMUS versus RMUS.

Validated QOL and incontinence severity measures

were assessed by Fan et al.35 in seven RCTs that

compared RMUS (TVT) and TMUS (TVT-O). A meta-

analysis of six trials measuring Urogenital Distress

Inventory scores found a statistically significant

weighted mean difference favoring TMUS slings (2.28,

95% CI: 1.77 to 2.80). Meta-analyses of other

instrument scores (IIQ, VAS, ICIQ-SF, and UISS) found

no significant between-group differences, but the 95%

confidence intervals were all too wide to rule out the

possibility of a difference between treatments. Schimpf

et al.36 found no significant difference in patient

satisfaction between TMUS or RMUS.

Significant differences in adverse events were identified

in both the systematic review and in individual RCTs.

While the systematic reviews did not provide enough

information on patient characteristics to separate index

from non-index patients, seven of the individual RCTs

reviewed reported data on index patient’s only.

Ford et al.20 found more major vascular or visceral

injuries, bladder or urethral perforations, voiding

dysfunction, and suprapubic pain with the RMUS, while

groin pain, repeat incontinence surgery between one

and five years, and repeat incontinence surgery after

more than five years were more likely to occur with the

TMUS. Sun et al.33 noted higher rates of bladder

perforation, hematoma, and voiding dysfunction with

the RMUS and higher rates of thigh/groin pain with the

TMUS. While most other adverse events outcomes were

inconclusive due to wide confidence intervals, de novo

urgency or UUI were equivalent between the two

procedures.

In summary, the balance of evidence suggests

equivalence in efficacy, QOL improvement, and

satisfaction between the TMUS and RMUS, particularly

within the first few years after surgery. Longer-term

data are less clear, with some studies showing lower

likelihood of the need for repeat treatment after RMUS.

Adverse events differed with the TMUS having a lower

risk of intraoperative injury and voiding dysfunction,

while the RMUS has lower rates of short-term groin

pain and need for repeat stress incontinence surgery.

a. When performing TMUS in women with stress

-predominant urinary incontinence surgeons






18

may perform either the in-to-out or out-to-in

TMUS technique.

Data from 10 RCTs of both index and non-index

patients are consistent in finding equivalence between

the two approaches. Ford et al.20 performed a meta-

analysis that included 10 trials with a total of 1,463

women with SUI or MUI with stress- predominant

symptoms that compared the outside-in and inside-out

TMUS. Subjective and objective cure at various follow-

up times indicated equivalence between the

procedures. One trial demonstrated a significant mean

difference of 16.54 (95% CI: 4.84 to 28.24) in IIQ-7

scores favoring the inside-out procedure. Adverse

events were different with vaginal perforation occurring

more frequently with the outside-in approach and

voiding dysfunction occurring more frequently with the

inside-out approach. Four additional RCTs of moderate

and high quality were consistent with the conclusion of

equivalence between the two approaches.39,48-51

b. When performing RMUS in women with

stress-predominant urinary incontinence

surgeons may perform either the bottom-up or

the top-down approach.

Most studies comparing the top-down to the bottom-up

technique demonstrated equivalence or were

inconclusive. The systematic review by Ford et al.20

detected a statistically significant difference in the

subjective cure rates favoring the bottom-up approach;

however, the relative risks for both the subjective and

objective cure rates fell within the equivalence range.

The top-down approach had higher rates of bladder and

urethral perforation, voiding dysfunction, and vaginal

tape erosion while an analysis of other adverse events

such as perioperative complications, de novo urgency

or urgency incontinence, and detrusor overactivity was

inconclusive due to wide confidence intervals. Lord et

al.26 identified higher rates of urinary retention with the

top-down approach (6.5%) versus the bottom-up

approach (0%). Panelists felt that the limited evidence

from one review demonstrating a small increase in

adverse events with the top-down approach was

insufficient to make a recommendation favoring the

bottom-up approach over the top-down approach.

c. A MUS may be considered in the non-index

patient or in the patient with intrinsic

sphincter deficiency after appropriate

evaluation and counseling.

Very few of the meta-analyses or individual studies

restricted the enrollment to index patients. Studies that

restricted to index patients had similar comparative

outcomes to those studies that included some non-

index patients. Therefore, while there are no evidence-

based recommendations that the Panel can make

regarding placement of a MUS in patients who do not

fall into the definition of the index patient, the Panel

feels that it is important to consider several factors

when deciding whether or not to proceed with a MUS.

Considerations may include prior pelvic floor

reconstruction and technique, temporal relationship to

any prior surgery, presence or absence of pelvic

prolapse, degree of urethral mobility, concomitant and

urinary urgency or urgency incontinence symptoms.

Regarding patients with ISD (typically defined as VLPP

<60 cm water and/or minimal urethral hypermobility),

one review evaluated the comparative efficacy of RMUS

and TMUS in 8 RCTs with a total of 399 patients with

ISD-associated SUI or MUI. A meta-analysis of

subjective cure rate at up to 5 years follow up found a

statistically significant difference favoring RMUS,

although the effect size was quite small and the 95%

confidence interval fell within the range of equivalence

(RR 0.88, 95% CI: 0.80 to 0.96). A meta-analysis of

objective cure rate at up to 5 years found no

statistically significant between-group difference, but

the effect size and 95% confidence interval was similar

to that for subjective cure (RR 0.90, 95% CI: 0.79 to

1.03). They also meta-analyzed 2 RCTs with 183

patients with ISD-associated SUI or MUI that performed

QOL assessment.34 In general, this review found

equivalent effectiveness between the two treatments.

However, they found that repeat incontinence surgery

within five years was significantly lower in the RMUS

group. One RCT42 confirmed the conclusion of Ford et

al. (2015)20 that the rate of repeat sling surgery within

one to five years is lower (better) after RMUS than after

TMUS.

14. Physicians may offer single-incision slings to

index patients undergoing midurethral sling

surgery with the patient informed as to the

immaturity of evidence regarding their

efficacy and safety. (Conditional

Recommendation; Evidence Level: Grade B)

SIS products were introduced into the market since the

last review and have continued to evolve over time

leading to inconsistent evidence regarding their efficacy

and safety. Some evidence has suggested that SIS are

associated with low rates of postoperative groin pain,

but higher rates of vaginal mesh exposure and mesh

perforation into the bladder or urethra. However, these

higher rates appeared predominantly in meta-analyses/

studies that included TVT-Secur, which has been






19

withdrawn from the market.

Three systematic reviews and 13 additional publications

addressed the comparison of the transobturator

midurethral sling with the single-incision sling. Most of

the trials were of short duration, and a variety of SIS

were used in the trials. Of the 13 individual RCTs that

were reviewed, 4 utilized a non TVT-Secur SIS, and all

showed similar effectiveness between the SIS and the

TMUS. After removing the trials that included TVT-

Secur, the remaining trials consistently suggest similar

efficacy between the TMUS and a variety of currently

marketed SIS.

Nambiar et al.28 included 20 trials that compared

adverse events between SIS and either inside-out or

outside-in TMUS. After removing the 8 trials that

utilized TVT-Secur as the SIS, the remaining 12 trials

were inconclusive with regard to efficacy. While they

did not show any differences in subjective or objective

cure rates, the confidence intervals were too large to

rule out a significant difference.

Zhang et al.52 used more specific selection criteria,

including five RCTs that compared the SIMS-AJUSTsling

to TVT-O or TOT slings. They demonstrated equivalence

in both objective and subjective cure rates.

Fan et al. (2015)35 assessed the impact on validated

incontinence impact instruments using eight RCTs that

compared SIS (two used TVT-Secur) to TVT-O slings. A

meta-analysis of five trials using the PISQ-12 found

significantly higher sexual function scores in the SIS

group. One trial using the KHQ found significantly

greater improvement in the total KHQ score in the

TMUS group, while the other instruments yielded

inconclusive results, as they did not find a significant

difference between treatments.

The literature regarding adverse events following SIS is

inconsistent. In one study, data regarding four specific

adverse events favored TMUS over SIS: less vaginal

mesh exposure, less mesh perforation into the bladder

or urethra, greater need for repeat SUI surgery, and

greater need for any other additional or new surgical

procedure. In contrast, meta-analyses of these same

outcomes comparing TMUS and SIS were inconclusive.

While both postoperative and long-term pain and

discomfort favored SIS when compared to TMUS, all

other outcomes, meta-analyses were inconclusive.

A meta-analysis of postoperative groin pain found a

significant reduction favoring the SIMS-AJUST sling.

Meta-analyses for other adverse events (including

postoperative pain, lower urinary tract injuries,

postoperative voiding difficulties, de novo urgency and/

or worsening of preexisting surgery, vaginal tape

erosion, and repeat continence surgery) were

inconclusive.

Five additional publications compared SIS other than

TVT-Secur with the TMUS. Franco et al.53 found

inconclusive results except that pain was less after

Contasure Needless (C-NDL) when compared to TMUS.

Foote54 and Schellart et al.55 also found less pain with

the MiniArc SIS versus the TMUS and inconclusive

results for other adverse events. Mostafa et al.56 and

Schweitzer et al.57 compared TVT-O to SIMS-AJUST and

found comparative adverse event rates to be

inconclusive.

The Panel felt that longer-term data were necessary

before being able to make a stronger statement

regarding the SIS. The current data, while

demonstrating similar efficacy to TMUS, are generally

limited to short-term (12 months) trials involving

substantially fewer patients than trials involving full

length RMUS or TMUS.

15. Physicians should not place a mesh sling if the

urethra is inadvertently injured at the time of

planned midurethral sling procedure. (Clinical

Principle)

Given the risks of mesh erosion the Panel felt that in

cases where the urethra has been entered

unintentionally, mesh procedures for SUI should be

avoided. If the surgeon feels it is appropriate to

proceed with sling placement in the face of an

inadvertent entry into the urethra, then a non-synthetic

sling should be utilized.

16. Physicians should not offer stem cell therapy

for stress incontinent patients outside of

investigative protocols. (Expert Opinion)

The Panel recognizes that stem cell therapy may be a

future option for women with SUI; however, there is

currently not enough data to support this treatment

modality. Future studies are necessary to identify the

best cell type and technique as well as patient

characteristics to guide treatment decisions.

SPECIAL CASES

17. In patients with stress urinary incontinence

and a fixed, immobile urethra (often referred

to as ‘intrinsic sphincter deficiency’) who wish

to undergo treatment, physicians should offer

pubovaginal slings, retropubic midurethral

slings, or urethral bulking agents. (Expert

Opinion)






20

There are multiple deficiencies in the literature with

regard to ISD, including the definition of ISD, the

coexisting morbidities, the variable outcomes measures

and the variability in the procedures that have been

performed and evaluated in the literature.

While there are a number of trials that have compared

one procedure to another in patients with ISD, they are

usually subanalyses of larger trials. Some argue that a

MUS should be avoided in a patient with an immobile

urethra because the mechanism of action by which the

MUS corrects incontinence is by compressing the

urethral lumen as it moves into the sling with increased

intraabdominal pressure. The immobile urethra may

require additional tension on the sling, which should be

avoided when using mesh slings. Nevertheless, in

situations in which a MUS is being considered, there is

some data suggesting that the RMUS is preferred over

the TMUS.58

The Panel believes that in the case of a minimally

mobile urethra, RMUS or PVS may a preferred option,

and in the case of the non-mobile urethra, PVS may be

the preferred option. Other techniques that have been

used effectively in this scenario include the spiral

(circumferential) sling using autologous fascia, and the

artificial urinary sphincter.59,60

Bulking injections have been shown to be effective in

this setting as well; however, the risk of SUI

recurrence, and the likely need for future injections

should be discussed with the patient.

Overall the consensus of the Panel was that while RMUS

and bulking agents may be considered in these

settings, the autologous PVS is a preferred approach

based on the lack of robust evidence for RMUS in these

patients, the suboptimal outcomes with bulking

injections and the long track record of PVS.

18. Physicians should not utilize a synthetic

midurethral sling in patients undergoing

concomitant urethral diverticulectomy, repair

of urethrovaginal fistula, or urethral mesh

excision and stress incontinence surgery.


It is a well-accepted principal that synthetic mesh

should not electively be placed in close proximity to a

fresh opening into the genitourinary tract. High level

evidence supporting or refuting this is noticeably

lacking given the extant case reports suggesting

urethral erosion associated with mesh slings. Mesh

placed in close proximity to a concurrent urethral

incision can theoretically affect wound healing,

potentially resulting in mesh perforation. Thus, a

synthetic sling should not be placed concurrently with

any procedure in which the urethra is opened in

proximity to the sling position. Specifically, if a

concurrent anti-incontinence procedure is necessary

when performing a urethral diverticulectomy,

urethrovaginal fistula repair, or removal of mesh from

within the urethra, a synthetic sling should not be

utilized. Instead, an anti-incontinence procedure that

does not involve placement of synthetic material

suburethrally, or use of a biologic material, preferably

autologous fascia, should be considered.

19. Physicians should strongly consider avoiding

the use of mesh in patients undergoing stress

incontinence surgery who are at risk for poor

wound healing (e.g., following radiation

therapy, presence of significant scarring, poor

tissue quality). (Expert Opinion)

Proper healing of the vaginal epithelium is critical in the

prevention of mesh exposures. Compromised tissue

may heal poorly, thereby increasing the risk for

complications when mesh is placed. Patients with poor

tissue characteristics (e.g., following radiation therapy,

significant fibrosis from prior vaginal surgery, severe

atrophy) are at increased risk for complications

following synthetic mesh placement. Other chronic

states that lead to impaired wound healing, such as

long-term steroid use; impaired collagen associated

with systemic autoimmune disorders, such as visceral

Sjogren’s disease or systemic lupus erythematosus;

and immune suppression may also increase the risk of

a mesh exposure. Physicians should consider the

presence of other comorbid conditions and treatments

that may affect wound healing (e.g., radiation therapy,

presence of significant scarring, poor tissue quality)

when selecting sling type in patients undergoing stress

incontinence surgery. In such cases, alternatives to

synthetic mesh should be considered, although there is

no direct evidence that patients are at increased risk of

urethral perforation in these circumstances.

20. In patients undergoing concomitant surgery

for pelvic prolapse repair and stress urinary

incontinence, physicians may perform any of

the incontinence procedures (e.g., midurethral

sling, pubovaginal sling, Burch

colposuspension). (Conditional

Recommendation; Evidence Level: Grade C)

SUI may coexist with pelvic organ prolapse in a

significant number of patients. Women with preexisting

SUI may have worsening of urinary incontinence, and

some without any symptoms of SUI may develop stress

leakage following reduction of the prolapse. Physicians






21

may choose to perform a concomitant incontinence

procedure when repairing pelvic organ prolapse;

however, they must balance the benefits with the

potential for an unnecessary surgery and possible

additional morbidity. Several caveats are important in

the consideration of this clinical scenario. Three general

approaches can be considered: (1) perform a

concomitant incontinence procedure in all women

undergoing prolapse surgery, (2) perform an

incontinence procedure in none, and (3) selectively

perform an anti-incontinence procedure based on the

presence of preexisting SUI and/or the finding of occult

SUI (SUI that only becomes apparent when the

prolapse is reduced). Informed patient decision-making

is critical in this situation. A nomogram has been

developed that can help estimate the risk of developing

SUI after vaginal prolapse surgery and can aid in the

decision regarding whether or not to perform a

concomitant anti-incontinence procedure.61

When specifically considering patients without SUI

symptoms preoperatively, two important studies

provide guidance. The CARE trial showed that women

undergoing an abdominal sacrocolpopexy without

preoperative complaints of SUI who had a concomitant

Burch colposuspension had a lower rate of

postoperative SUI than those who did not have a Burch

colposuspension.62 Even when occult SUI was not

demonstrated preoperatively, those who had the Burch

colposuspension had a lower chance of developing SUI

postoperatively. The OPUS trial randomized patients

undergoing a vaginal repair of stage 2 or greater

anterior vaginal wall prolapse, without symptoms of

SUI, to either undergo a concomitant RMUS or sham

incision (i.e., no surgery for SUI).63 At 12 month follow-

up, those who had a concomitant sling had a lower rate

of SUI than those who did not. However, it is important

to recognize that the difference was not marked

(27.3% SUI in those that had a sling and 43.0% in

those that did not). Critically, the number of patients

needed to treat with a sling to prevent one case of

incontinence was 6.3. Thus, one could argue that 5 of 6

patients who had a sling placed had an unnecessary

procedure with the additional (small but real) risk of

increased morbidity.

Ultimately, the decision as to whether or not to perform

a concomitant incontinence procedure at the time of

prolapse surgery should be a product of a shared

decision making process between the physician and

patient after a review of the risks and benefits of this

additional procedure.

21. Physicians may offer patients with stress

urinary incontinence and concomitant

neurologic disease affecting lower urinary

tract function (neurogenic bladder) surgical

treatment of stress urinary incontinence after

appropriate evaluation and counseling have

been performed. (Expert Opinion)

Patients with neurogenic lower urinary tract dysfunction

may have straightforward SUI or SUI related to their

neurologic process. In either event, patients with

neurogenic lower urinary tract dysfunction do not fall

into the category of the index patient, and a detailed

evaluation should be performed. Other issues, such as

incomplete emptying, detrusor overactivity, and

impaired compliance, should be identified and in many

cases treated prior to surgical intervention for SUI. In a

patient who requires intermittent catheterization, one

must be cognizant of possible complications with the

use of a bulking agent (bulking effect may be

attenuated by frequent catheter passage) or a synthetic

sling (potential catheter trauma in the area of the sling

could place the patient at risk for mesh erosion into the

urethra). These concerns must be discussed relative to

the overall risks and benefits of the procedure. Should

the sling need to be placed under tension with the goal

of planned permanent surgical retention, clinical

judgement would suggest that the procedural choice

should be a non-mesh sling. Lastly, patients with

neurogenic lower urinary tract dysfunction who undergo

sling procedures in particular should be followed long-

term for changes in lower urinary tract function that

could be either induced over time by the neurologic

condition itself, or potentially by the sling procedure.

22. Physicians may offer synthetic midurethral

slings, in addition to other sling types, to the

following patient populations after

appropriate evaluation and counseling have

been performed: (Expert Opinion)

Patients planning to bear children

Diabetes

Obesity

Geriatric

The Panel believes that in most instances, placement of

a sling should be postponed until child bearing is

complete. Overall, there does appear to be a relatively

high rate of SUI recurrence following delivery,

independent of mode of delivery, among women with a

history of MUS. In light of the elective nature of the

surgery, the Panel suggests that in most instances,

surgical treatment of SUI should be deferred until after






22

child bearing is complete.

Diabetic women planning to undergo sling surgery

should be counseled regarding their higher risk for

mesh erosion and reduced effectiveness compared with

their non-diabetic counterparts. There is some overlap

with obesity in this category; however, after controlling

for obesity, diabetes was found to have a negative

impact on outcomes.21,22,64-67

Obesity (defined as a BMI of > 30) has been well

studied in several trials, and there appears to be a

slight correlation suggesting worse clinical effectiveness

of slings in obese patients compared with those with

lower BMI. Increased risk of voiding dysfunction and

mesh erosion were not found to be associated with

obesity.21,24,43,68,69

Geriatric patients (defined as 65 years old or older in

most studies) undergoing incontinence surgery should

be counseled that they are at lower likelihood of

successful clinical outcomes compared with younger

patients. No clear association is noted between age and

mesh erosion or voiding difficulty in patients

undergoing MUS surgery.

Due to the lack of robust data regarding various patient

populations, there are no evidence-based

recommendations that the Panel can make regarding

the use of MUS in non-index populations, such as those

with high-grade prolapse, high BMI, advanced age, or

recurrent or persistent SUI. However, the Panel does

feel that there are a number of factors that should be

considered when making the decision to proceed with a

MUS in these patients. These may include the type of

previous surgery, length of time since previous surgery,

presence or absence of hypermobility, degree of

urgency or urgency incontinence symptoms, and other

potential contributing factors.

OUTCOMES ASSESSMENT

23. Physicians or their designees should

communicate with patients within the early

postoperative period to assess if patients are

having any significant voiding problems, pain,

or other unanticipated events. If patients are

experiencing any of these outcomes, they

should be seen and examined. (Expert

Opinion)

Early intervention may ameliorate potential

complications in patients who have had SUI surgery.

Specifically, if there is evidence a patient has symptoms

of obstruction, early intervention may be necessary to

reduce patient bother and to prevent development of

bladder dysfunction in the long-term. Other

postoperative complications, such as dyspareunia,

persistent pain, frequent UTI, and mesh-specific

complications, such as vaginal extrusion and lower

urinary tract erosion, might also be more expeditiously

and effectively treated with early communication.

Because patients may not recognize some of the

potential adverse events that can occur, they may

suffer unnecessarily if the appropriate questions and

assessment are not performed. Though clearly this

communication can be in person, there is no evidence

that a phone discussion cannot provide the same

information.70 Recent evidence would suggest that

verbal communication potentially supplemented by live

internet-based communication (tele-medicine) of

wounds can suffice for follow up evaluation in

uncomplicated post-operative scenarios and can

identify surgical complications expeditiously when

present.71 If patients are having voiding dysfunction, a

decrease in the force of their urinary stream,

unexpected pain, recurrent UTI, new onset

dyspareunia, or other unanticipated symptoms, they

should be evaluated in person by the physician or his/

her designee. If appropriate, depending on the index

surgery, the patient can be taught clean intermittent

catheterization (CIC), a catheter can be placed, or

surgical intervention may be necessary. Additionally, in

circumstances of preoperative concern related to

postoperative voiding dysfunction (e.g. poor quality

bladder contraction identified on urodynamic

evaluation), CIC instruction should be considered as a

component of preoperative teaching.

24. Patients should be seen and examined by their

physicians or designees within six months

post-operatively. Patients with unfavorable

outcomes may require additional follow-up.

(Expert Opinion)

The subjective outcome of surgery as

perceived by the patient should be assessed

and documented.

Patients should be asked about residual

incontinence, ease of voiding/force of stream,

recent urinary tract infection, pain, sexual

function and new onset or worsened

overactive bladder symptoms.

A physical exam, including an examination of

all surgical incision sites, should be performed

to evaluate healing, tenderness, mesh

extrusion (in the case of synthetic slings), and

any other potential abnormalities.






23

A post-void residual should be obtained.

A standardized questionnaire (e.g. PGI-I) may

be considered.

At some point between six weeks and six months after

surgery, the patient should be assessed and examined

in person by the surgeon or his/her designee to

evaluate the outcomes of surgery and to assess for any

potential complications.

At the time of follow-up, the subjective outcome of

surgery as perceived by the patient should be assessed

and documented. Information related to resolution of

SUI, need for pads and number used, presence or

absence of OAB symptoms, ease of voiding/force of the

urinary stream as well as other pertinent lower urinary

tract symptoms should be elicited. New onset surgical

site or pelvic pain and dyspareunia should also be

explicitly queried.

Completion of a standardized questionnaire by the

patient at this visit to assess her satisfaction may be

considered. The PGI-I is an easy to use and responsive

form that correlates well with other outcomes

questionnaires and can be used to facilitate

comparisons between centers. It is recommended,

though several objective, validated incontinence

questionnaires are also available for this purpose and

can be utilized.72-77 For physicians who utilize a

validated lower urinary tract questionnaire in the initial

evaluation of their patients with SUI, repeating the

same questionnaire postoperatively is recommended.

Sexual function, including whether the patient or their

partner is experiencing any pain during intercourse,

should be assessed. Patients should also be asked

about any UTIs since surgery.

A physical exam should be performed and a PVR should

be measured.

A pelvic exam as well as an abdominal/thigh exam,

depending on the surgery performed, should be

performed to assess for wound healing at the surgical

sites. Tenderness at any trocar sites (prepubic/thigh) or

incisions should be evaluated, to rule out infection,

hematoma, or extruded mesh and to document a

baseline for longitudinal comparison. A vaginal exam

should be performed to assess for any delay in healing,

tenderness, potential wound disruption, and in the case

of synthetic slings, mesh exposure. While exposure can

be identified visually during a half-speculum exam

palpation of the anterior vaginal wall may also identify

mesh exposure that is not easily visible. If the index of

suspicion is high in spite of inability to definitively

identify extruded mesh, an examination under

anesthesia can be considered. Wound complications

specifically associated with autologous harvest sites

(seroma, hernia) should also be assessed.

FUTURE DIRECTIONS

Continued emphasis on outcomes reporting has placed

more focus on the importance of patient literacy in the

informed consent process and the perioperative

preparation schema. It is generally accepted that

appropriate informed consent relies on adequate

patient information and instruction. It is also clear that

the complexity of functional urologic conditions such as

female SUI provide unique and significant hurdles to

patient understanding and appropriate determination of

risk/benefit related to interventions for these

conditions. Increased reliance on non-paper-based

informational resources has evolved given the

understanding that adult education requires repetitive

delivery of information in discreet and discernable

informatics groupings. Expanded use of tests of

functional health literacy in adults (TOFHLA) may

expedite literacy assessments in unique individuals.

Improving and honing a physician’s ability to provide

valuable and comprehensible education for patients

regarding their condition and therapeutic options are of

clear importance in accomplishing successful treatment.

Patients who understand their condition and the

rationale behind their treatment are more satisfied with

their outcomes.78 Accordingly, the development of

ancillary tools that can supplement and move toward

more effective and successful communication between

patients and their surgeons would be of significant

worth. Similarly, overcoming obstacles that result in

disparities in healthcare, such as socioeconomic,

language, and access barriers would provide great

value to many.

The use of telemedicine in surgery is expanding rapidly

and across multiple specialties within surgical

disciplines. Telesurgery has been performed for the last

several decades, but the use of telemedicine, from a

standpoint of mentoring and consultation, has recently

become more popular. Although not completely

explored, some pelvic floor disorders would appear to

be uniquely suited to teleconsultation and telefollow-up

for purposes of managing chronic conditions, which

these disorders represent.79

In considering new treatments, stem cell injection for

the indication of SUI represents possibly one of the

most compelling emerging therapies. Stem cell use for

the treatment of SUI has been proposed for more than






24

ten years.80-83 Different stem cell populations have been

evaluated for this indication. The six cell types include

embryonic, muscle-derived (satellite cells), bone

marrow-derived,84 mesenchymal, adipose, urinary, and

human umbilical cord blood types. Human amniotic

fluid stem cells (hAFSCs) have also been proposed.85,86

Autologous muscle-derived cells (AMDSC) have been

evaluated for intrasphincteric injection for SUI.87 The

primary outcome was the incidence and severity of

adverse events. Treatment related complications

included minor events such as pain/bruising at the

biopsy and injection sites. A higher percentage of

patients receiving high doses (in terms of cell numbers)

experienced a 50% or greater reduction in pad weight,

had a 50% or greater reduction in diary-reported stress

leaks and had zero to one leak during a three-day

period at final follow-up.

Stem cell use for the indication of SUI continues to

evolve. Current evidence is limited by a lack of active

comparator arms and outcomes limitations.

Additionally, the optimal cell type, injection method,

and final administration characteristics for cell transfer

(inclusive of volume of viable cells) remain areas for

improvement and study.

It is anticipated that as materials science advances, the

use of nanoparticulate technology expands, and

improved understanding of wound healing evolves,

other therapies will arise for SUI. These therapies will

need to be carefully vetted and assessed for safety and

efficacy, and it is hoped that enhanced collaboration

between regulatory, academic, and patient outcomes

groups will provide continued improvement in

interventions for SUI.






25






26






27

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32

Stress Urinary Incontinence Panel, Consultants and Staff

Kathleen C. Kobashi, MD (Chair) Virginia Mason Seattle, WA Gary E. Lemack, MD (Vice Chair) UT Southwestern Dallas, TX Michael E. Albo, MD University of California, San Diego San Diego, CA Roger R. Dmochowski, MD, MMHC Vanderbilt University Nashville, TN David A. Ginsberg, MD Keck Medicine of USC Los Angeles, CA Howard B. Goldman, MD Cleveland Clinic Cleveland, OH Alexander Gomelsky, MD LSU Health Shreveport, LA Stephen R. Kraus, MD University of Texas San Antonio, TX Jaspreet S. Sandhu, MD Memorial Sloan Kettering Cancer Center New York, NY Tracy Shepler (Patient Advocate) Bow, WA Sandip P. Vasavada, MD Cleveland Clinic Cleveland, OH

Consultants

Jonathan R, Treadwell, PhD

Staff

Heddy Hubbard, PhD, MPH, RN, FAAN

Abid Khan, MHS, MPP

Erin Kirkby, MS

Shalini Selvarajah, MD

Nenellia K. Bronson, MA

Leila Rahimi

Brooke Bixler, MPH

CONFLICT OF INTEREST DISCLOSURES All panel members completed COI disclosures. Disclosures listed include both topic– and non-topic-related relationships. Consultant/Advisor: Kathleen C. Kobashi, Allergan, Medtronic; Gary E. Lemack, Allergan,

Medtronic; Michael E. Albo, Astora; Roger R. Dmochowski, Allergan, Medtronic, Serenity; David A. Ginsberg, Allergan; Howard B. Goldman, Medtronic, Pfizer, Axonics; Stephen R. Kraus, Allergan, Astellas; Jaspreet Sandhu, American Medical Systems; Sandip Vasavada, Allergan, Axonics Meeting Participant or Lecturer: Kathleen C. Kobashi, Astellas, Allergan; Gary E. Lemack, Astellas, Allergan; David A. Ginsberg, Allergan; Howard B. Goldman, Allergan, Astellas, Medtronic, P fizer; Stephen R. Kraus, Medtronic; Jaspreet Sandhu, American Medical Systems; Sandip Vasavada, Allergan; Scientific Study or Trial: Kathleen C. Kobashi, Medtronic; Roger R. Dmochowski, Myopowers; David A. Ginsberg, Allergan, Medtronic, NovaBay; Howard B. Goldman, Cook, Medtronic; Stephen R. Kraus, NIDDK; Sandip Vasavada, Allergan; Investment Interest: Sandip Vasavada, NDI Medical LLC; Other: Stephen R. Kraus, Laborie






33

Peer Reviewers We are grateful to the persons listed below who contributed to the Guideline by providing comments during the peer review process. Their reviews do not necessarily imply endorsement of the Guideline. Nitya Abraham, MD Peter C. Albertsen, MD Humphrey Atiemo, MD Timothy D. Averch, MD Diane Bieri Esq. Timothy Boone, MD Marissa Clifton, MD Craig Comiter, MD Jordan Dimitrakoff, MD James A. Eastham, MD Elizabeth Ferry, MD Farzeen Firoozi, MD Ghoniem Gamal, MD Angelo Gousse, MD Melissa R. Kaufman, MD Michael Kennelly, MD Stephanie Kielb, MD Ryan Krlin, MD Una Lee, MD Deborah J. Lightner, MD Alvaro Lucioni, MD Sarah McAchran, MD Alana Murphy, MD Charles Nager, MD Victor Nitti,MD Karen Noblett, MD Glenn M. Preminger, MD Leslie Rickey, MD Eric Rovner, MD Kamran Sajadi, MD Roger E. Schultz, MD Eila Curlee Skinner, MD Ariana Smith, MD Thomas F. Stringer, MD Suzette Sutherland, MD Chris Tenggardjaja, MD J. Brantley Thrasher, MD Christian Twiss, MD Tracey Wilson, MD J. Stuart Wolf, Jr., MD Guo-Bing Xiong, MD

DISCLAIMER

This document was written by the Stress Urinary Incontinence Guideline Panel of the American Urological Association Education and Research, Inc., which was created in 2014. The Practice Guidelines Committee (PGC) of the AUA selected the committee chair. Panel members were selected by the chair. Membership of the Panel included specialists in urology with

specific expertise on this disorder. The mission of the Panel was to develop recommendations that are analysis-based or consensus-based, depending on Panel processes and available data, for optimal clinical practices in the treatment of stress urinary incontinence.

Funding of the Panel was provided by the AUA and SUFU. Panel members received no remuneration for their work. Each member of the Panel provides an ongoing conflict of interest disclosure to the AUA.

While these guidelines do not necessarily establish the standard of care, AUA seeks to recommend and to encourage compliance by practitioners with current best practices related to the condition being treated. As medical knowledge expands and technology advances, the guidelines will change. Today these evidence-based guidelines statements represent not absolute mandates but provisional proposals for treatment under the specific conditions described in each document. For all these reasons, the guidelines do not pre-empt physician judgment in individual cases.

Treating physicians must take into account variations in resources, and patient tolerances, needs, and preferences. Conformance with any clinical guideline does not guarantee a successful outcome. The guideline text may include information or recommendations about certain drug uses (‘off label‘) that are not approved by the Food and Drug Administration (FDA), or about medications or substances not subject to the FDA approval process. AUA urges strict compliance with all government regulations and protocols for prescription and use of these substances. The physician is encouraged to carefully follow all available prescribing information about indications, contraindications, precautions and warnings. These guidelines and best practice statements are not in-tended to provide legal advice about use and misuse of these substances.

Although guidelines are intended to encourage best practices and potentially encompass available technologies with sufficient data as of close of the literature review, they are necessarily time-limited. Guidelines cannot include evaluation of all data on emerging technologies or management, including those that are FDA-approved, which may immediately come to represent accepted clinical practices.

For this reason, the AUA does not regard technologies or management which are too new to be addressed by this guideline as necessarily experimental or investigational.






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